FDA Related News

Human Drugs

CARES Act OTC Monograph Provisions Explained

Hyman, Phelps & McNamara outlines key provisions in the OTC monograph reform provisions included in the coronavirus recovery legislation.

Medical Devices

Lawmakers Press FDA on Covid-19 Test Accuracy

Two House lawmakers ask FDA to provide information about Covid-19 test accuracy in the wake of testing failures earlier this year involving Centers fo...

Medical Devices

Stimulation Device Final Rule Delay Sought

The Judge Rotenberg Center asks FDA to delay indefinitely the effective dates for a final regulation banning the use of electrical stimulation devices...

Biologics

Pfizer, BioNTech Developing Covid-19 Vaccine

Pfizer and BioNTech say they are working together on clinical trials and manufacturing capacity for an mRNA Covid-19 vaccine.

Human Drugs

Seneca Gets FDA Guidance on Phase 3 Trial

Seneca Biopharma says FDA has provided significant guidance on the design of a Phase 3 trial for the companys neural stem therapy intended to treat AL...

Stakeholder Comments on Biologics Advertising Q&A

Stakeholders comment on an FDA draft guidance on promotional labeling and advertising considerations for biological reference products and biosimilars...

Human Drugs

FDA Compounding Drug Updated Guidance

FDA issues policy clarifications for drug compounders during the Covid-19 pandemic.

Human Drugs

Manufacturing, Supply Chain Q&A

FDA posts a question-and-answer document on drug manufacturing and site changes during the Covid-19 pandemic.

Human Drugs

Acceleron Breakthrough for Pulmonary Hypertension Drug

FDA grants Acceleron Pharma a breakthrough therapy designation for sotatercept and its use in treating patients with pulmonary arterial hypertension.

Human Drugs

Dynamic Stem Cell Marketing Unapproved Biologics

FDA says Dynamic Stem Cell Therapy is marketing unapproved cellular products as treatments for many diseases and conditions.